Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Comparing Two Tapering Strategies of Prednisone in Myasthenia Gravis (MYACOR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00987116
First received: September 29, 2009
Last updated: September 16, 2014
Last verified: June 2012

September 29, 2009
September 16, 2014
June 2009
September 2014   (final data collection date for primary outcome measure)
Proportion of patients who have reach minimal manifestation state (according to MGFA criteria) and are not treated with prednisone after 12 months of treatment and have not relapsed during the next 3 months. [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00987116 on ClinicalTrials.gov Archive Site
  • Cumulative dose of prednisone at twelve months [ Time Frame: 15 MONTHS ] [ Designated as safety issue: Yes ]
  • Proportion of patients having reached minimal manifestation state 12 months [ Time Frame: 15 MONTHS ] [ Designated as safety issue: Yes ]
  • Time for reaching the improvement or minimal manifestation state (MGFA criteria) [ Time Frame: 15 MONTHS ] [ Designated as safety issue: Yes ]
  • Frequency of exacerbations within the first 15 months after randomization [ Time Frame: 15 MONTHS ] [ Designated as safety issue: Yes ]
  • Frequency of treatment by IvIg or plasma exchange within the first 15 months after randomization [ Time Frame: 15 MONTHS ] [ Designated as safety issue: Yes ]
  • Frequency and type of complications related to prednisone. [ Time Frame: 15 MONTHS ] [ Designated as safety issue: Yes ]
  • Frequency and type of complications of azathioprine [ Time Frame: 15 MONTHS ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Comparing Two Tapering Strategies of Prednisone in Myasthenia Gravis
Comparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter Study

Pathology - Generalized myasthenia gravis (MG) is cause of muscle weakness that can have a significant impact on daily life activity but can also be, when respiratory or bulbar muscles are involved, life-threatening.

Rationale - Additionally to thymectomy, which indication of is still debated in absence of thymoma, the long-term treatment of generalized myasthenia gravis includes usually prednisone and azathioprine. However, the most used scheme for prescribing and tapering corticosteroid in MG resulted in a very important cumulative dose of prednisone. Indeed, at twelve month, more than 50 percent of patients are still daily treated with at least 18 mg of prednisone and the proportion of patients who are in remission and no longer taking prednisone is very low (Palace and NEWSOM Davis, Neurology 1998). Prolonged corticosteroid therapy is accompanied with various and major side effects, hypertension, osteoporosis, weight gain, glaucoma. Therefore, tapering, eventually discontinuing, prednisone earlier is a relevant therapeutic goal.

For this reason, the investigators will compare to the standard one, a strategy consisting of a rapid decrease in corticosteroid.

Objective - To assess whether, in patients with generalized MG requiring a long-term treatment with corticosteroids and azathioprine, that the strategy of rapid tapering allows discontinuing more rapidly the prednisone for equivalent efficacy than the classical strategy.

Rapid strategy consists of decreasing the prednisone dose if at each monthly consultation the patient fulfils the criteria for improvement or minimal manifestation state, in order to discontinue it before twelve months. The starting dose is 0.75 mg/kg/day.

Classical strategy consists of decreasing the prednisone dose if at each monthly consultation the patient fulfils the criteria for minimal manifestation state, in order to discontinue it before twelve months. The starting dose is 1.5 mg/kg/2days.

Duration of follow-up is 15 months.

In both arms, Myasthenia Muscular Score (MMS), activities of Daily Living Scale (ADLS), MGFA Clinical Classification and MGFA Post-Intervention Status as well as prednisone and azathioprine side effects will be monthly assessed by a senior neurologist who will be blind for treatment group. A second physician, who is aware of the patient's therapeutic group, will then prescribe prednisone dose and tapering for a month, according to MGFA Post-Intervention Status.

In case of worsening, prednisone dose will be increased. In case of exacerbation, the patients will be hospitalised for eventually IvIg infusion or plasma exchange. In case of a severe side effect, prednisone will be reduced irrespectively of MGFA Post-Intervention Status. In case of side effect, azathioprine will be replaced by mycophenolate mofetil.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Myasthenia Gravis
Drug: Prednisone - Azathioprine

Rapid strategy consists of decreasing the prednisone dose if at each monthly consultation the patient fulfils the criteria for improvement or minimal manifestation state, in order to discontinue it before twelve months. The starting dose is 0.75 mg/kg/day.

Classical strategy consists of decreasing the prednisone dose if at each monthly consultation the patient fulfils the criteria for minimal manifestation state, in order to discontinue it before twelve months. The starting dose is 1.5 mg/kg/2days.

Other Name: Prednisone - Azathioprine
  • Active Comparator: Starting dose Prednisone Azathioprine
    Classical Strategy
    Intervention: Drug: Prednisone - Azathioprine
  • Active Comparator: Starting dose Prednisone - Azathioprine
    Rapid strategy
    Intervention: Drug: Prednisone - Azathioprine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
118
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written consent of the patient, after informing
  • Generalized MG of grade III, IV or V - Classification MGFA
  • Follow-up on 15 months possible and accepted by patients

Exclusion Criteria:

  • Age<18 or >80 years
  • Pregnancy
  • Myasthenia of grade I or II of MGFA
  • Patients already treated with prednisone or azathioprine
  • Contraindication for prednisone or azathioprine
  • Other associated disease requiring a treatment with prednisone or azathioprine
  • Weight >100kg
  • Invasive thymoma
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00987116
P051055
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Tarek Sharshar, MD PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP